Class 4 Medicines Defect Information: Diflucan Oral Suspension 40mg/ml (Star Pharmaceuticals Limited)

Drug alert number: EL (24)A/36

Date issued: 12 August 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Diflucan Oral Suspension 40mg/ml (Star Pharmaceuticals Limited)

Company name: Star Pharmaceuticals Limited

Product name: Diflucan Oral Suspension 40mg/ml (Star Pharmaceuticals Limited), PLPI 20636/3070

SNOMED Code: N/A

Batch Number
Expiry Date
Pack Size
First Distributed

B861104
09/2026
35 ml
20/05/2024

B694104
12/2024
35 ml
11/06/2024

Active Pharmaceutical Ingredient: fluconazole

Brief description of the problem

Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.

Section 6 of the PIL states “50mg of fluconazole per 5ml” instead of “200mg of fluconazole per 5ml”. The other sections of the PIL and product information state the correct strength of 200mg of fluconazole per 5ml.

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batch is not being recalled. Healthcare professionals should continue to use the product as normal but be aware of the typographical error highlighted in this notification. Star Pharmaceuticals Limited have also confirmed that they have identified all customers who have been supplied with this product and will initiate direct contact with the relevant customers.

View full alert here.

Advice for patients

No further action is required by patients. If you have received or receive the impacted batches of Diflucan Oral Suspension 40mg/ml listed in this notification, please continue to take your medicine as prescribed by your doctor and as per the dispensing label. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

For stock control enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

The post MHRA Class 4 Medicines Defect Information: Diflucan Oral Suspension 40mg/ml (Star Pharmaceuticals Limited) appeared first on Community Pharmacy England.